(87 days)
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.
Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis).
Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect
The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Genex® is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process.
Genex® is completely resorbed and replaced with bone during the healing process.
Genex® is provided sterile for single use only
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. The document is a 510(k) summary for a bone void filler called Genex®, dating from 2008.
The document discusses:
- Device Description: Genex® as a calcium salt bone graft substitute.
- Intended Use/Indications: For bony voids or defects not intrinsic to stability, to be packed/injected into the skeletal system.
- Summary of Technology & Non-Clinical Testing: States that Genex® has the same technological characteristics as the predicate device and is substantially equivalent. It notes that "Data supplied demonstrates that Genex® is substantially equivalent to the predicate device and any differences do not any concerns regarding safety and effectiveness." This implies non-clinical testing was done, but the details of the specific tests, their methodologies, and acceptance criteria are not provided.
- Substantial Equivalence: Asserts that indications, contraindications, risks, and potential adverse events are the same as the predicate device.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is focused on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that does not typically involve the kind of performance studies with specific acceptance criteria and ground truth validation that you've described for AI/ML devices.
To answer your questions accurately, I would need a document that describes the development and validation of an AI/ML medical device, including performance metrics, test sets, ground truth establishment, and study designs.
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NOV 1 4 2008
510(k) SUMMARY
Genex®
- Biocomposites Ltd Applicant Keele Science Park Keele Staffordshire England ST5 SNL
Mr Simon Fitzer Contact Person +44 (0) 1782 338580 Tel: +44 (0) 1782 338599 Fax Email: sf@biocomposites.com
Classification Name: Common/Usual Name: Trade/Proprietary Name Product Code
Filler, bone void, calcium compound Bone void filler Genex® MQV
Device Description
Genex® is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process.
Genex® is completely resorbed and replaced with bone during the healing process.
Genex® is provided sterile for single use only
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Intended Use / Indications
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.
Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis).
Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect
The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Summary of Technology
Genex® has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Non Clinical Testing
Data supplied demonstrates that Genex® is substantially equivalent to the predicate device and any differences do not any concerns regarding safety and effectiveness.
Substantial Equivalence
The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent.
Documentation provided demonstrates that the Genex® is substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the subject device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2008
Biocomposites Ltd % Mr. Simon Fitzer Keele Science Park Keele, Staffordshire England ST5 5NL
Re: K082381 Trade/Device Name: Genex® Regulation Number: 21 CFR 888.3045 Regulation Names: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 8, 2008 Reccived: August 19, 2008
Dear Mr. Fitzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Simon Fitzer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Genex® Device Name:
Indications For Use:
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.
Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis).
Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect
The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
V Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter use (Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.W. mo Rimm
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number K062381 Page 1 of 1
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.